Category Archives: News

By Kieryn Graham 

As seen on AIDSBeacon.com

Results from a recent study suggest that stimulation of immune cells that specifically target HIV is necessary to eradicate latent HIV. The results also suggest that simply activating latent HIV is not sufficient to eliminate the virus from the body.

 

Based on the results, the researchers suggested that boosting immune responses through vaccination, followed by reactivation of latent HIV, may be an effective strategy for eradicating HIV.

 

Latent HIV is HIV that is not actively replicating. Since antiretroviral drugs usually work by blocking replication, they do not work on latent HIV. Many researchers believe that activating latent HIV is the key to curing HIV infection; once HIV is activated and begins replicating, scientists hope it will become susceptible to elimination.

 

To date, efforts to cure HIV have focused on reactivating latent HIV virus without activating immune cells. Several drugs have been shown to reactivate latent HIV virus in laboratory studies, including valproic acid (Depakote), Zolinza (vorinostat) (see related AIDS Beacon news), and disulfiram (Antabuse) (see related AIDS Beacon news).

 

According to the study investigators, a critical issue that has not yet been resolved is the fate of infected cells after the virus is reactivated. It is believed that the infected cells die after the virus is reactivated, either as a result of viral replication, or immune system responses, or both.

 

However, the investigators noted that it has not yet been determined whether cells infected with latent HIV are eliminated following reactivation of the virus.

 

In this laboratory-based study, researchers used Zolinza to reactivate latent HIV in CD4 (white blood) cells, then monitored whether the cells died. They also tested the effects on infected CD4 cells of stimulating a type of immune cell called cytolytic T lymphocytes, which are responsible for killing infected cells.

 

The study included 14 HIV-positive adults on highly active antiretroviral therapy (HAART). The investigators treated cells taken from the study participants with Zolinza for six days. They then measured the number of HIV-infected CD4 cells that survived.

 

Results showed that despite successful reactivation of latent HIV, infected CD4 cells were not eliminated. Infected cells were detected in 100 percent of samples treated with Zolinza, in similar amounts to those detected in samples not treated with Zolinza.

 

According to the researchers, this result suggests that reactivation of latent HIV virus alone is not sufficient to eliminate the latent HIV reservoir in CD4 cells.

 

The researchers then examined the ability of participants’ cytolytic T lymphocytes to kill infected CD4 cells.

 

Results showed that only 12 percent of study participants on HAART had cytolytic T lymphocytes that killed CD4 cells infected with latent HIV. The researchers suggested that the weak cytolytic T lymphocyte responses in these patients could be the result of too few HIV-specific cytolytic T lymphocytes or due to reduced function of these cells.

 

However, when researchers stimulated cytolytic T lymphocytes with HIV proteins for six days prior to reactivating latent HIV, the clearance of infected CD4 cells increased significantly.

 

In participants for whom almost no cytolytic T lymphocyte activity was observed without stimulation, the average time to halve the number of CD4 cells infected with latent HIV was reduced from 34 days to less than four days when cytolytic T lymphocytes were stimulated.

 

For more information, please see the study in the journal Immunity

 

 

 

 

 

Howard Brown to pay $715,000 to settle claims of misusing grants

By: Kristen Schorsch April 02, 2012

Article from Chicagobusiness.com

Howard Brown Health Center has agreed to pay $715,000 to several federal agencies to settle allegations that the North Side organization mismanaged grant money.

The agreement resolves an investigation by the inspector general of the U.S. Department of Health and Human Services into the clinic’s handling of more than $3 million between 2005 and 2010.

Howard Brown revealed in April 2010 that it was cooperating with federal authorities on an investigation into the use of federal grant money for a major HIV/AIDS study. Later that year, Howard Brown turned over results of an internal audit showing that grants likely had been used to cover operating expenses during cash shortfalls.

Separately, Howard Brown also plans to repay $1.7 million to Northwestern University, said Jamal Edwards, who assumed the CEO post at Howard Brown after the possible financial mismanagement was detected. Northwestern became the lead agent for the HIV/AIDS study after Howard Brown became the subject of investigation.

The settlement, which covers grants tied to three studies or programs, is a key step in a turnaround of the North Side health clinic network, which was founded in 1974.

“It’s really the first day of the rest of our lives at Howard Brown,” Mr. Edwards said.

The settlement will also place added urgency on fundraising, which Mr. Edwards already has made a priority.

“We certainly do need people to continue to support us,” he said. “Obviously this is going to cause us to redirect a lot of our funds to debt repayment and not services as we would like.”

A pioneer in the treatment of people with HIV and AIDS, Howard Brown is also a research center.

Under the terms of the agreement finalized Friday, Howard Brown is making an immediate payment of $140,000 to the Centers for Disease Control and Prevention and to an agency of Health and Human Services, Mr. Edwards said.

The remaining amount, $575,000, will be paid over three years to the National Institutes of Health, he said.

Details for repaying Northwestern haven’t been finalized, and the repayment likely will take place over the next few years, Mr. Edwards said.

The Office of the Inspector General of Health and Human Services declined to comment.

The federal agencies were seeking $1.1 million, an amount that could have been tripled, Mr. Edwards said.

That Howard Brown turned over its internal audit and cooperated with federal authorities was a key factor in reaching the settlement, he said.

Since becoming chief executive, Mr. Edwards says he has overhauled the clinic’s board and administration and put in place new internal controls and auditing processes.

The organization must still boost revenue, which fell 10 percent, to $16.2 million during the fiscal year ended June 30, from $18.0 million in the prior fiscal year. Mr. Edwards has tried to offset falling revenue by putting renewed emphasis on fundraising and by cutting spending. Expenses were reduced by 26 percent, to $15.0 million in 2011, from $20.2 million in 2010.

CHIPTS is now on UCLA ItunesU!

UCLA ItunesU is a free, hosted service for colleges and universities that provides easy access to educational content, including lectures and interviews.  It is a pilot project in conjunction with Apple Inc., which allows them to distribute digital content via the iTunes desktop application.

Organizations and UCLA instructors may upload content— audio, video and PDF files — to the UCLA on iTunes U site. The content can then be downloaded and played on computers or portable devices.

We have already uploaded two lecture podcasts.  Go to ItunesU and check it out!

From AIDSinfo

 

Download revision here:  [Download not found]

Download entire guidelines here:  [Download not found]

What’s New in the Guidelines?

Revisions to the October 14, 2011, version of the guidelines include both new sections and key updates to existing sections. The additions and updates, which are highlighted throughout the guidelines, are summarized below.

New Sections

The following new sections have been added to the guidelines.

HIV and the Older Patient
Effective antiretroviral therapy (ART) has led to greater longevity in HIV-infected individuals resulting in an increasing number of older individuals living with HIV infection. Compared with younger HIV-infected patients, older patients may have more comorbidities, which can complicate treatments of HIV and other diseases. This section focuses on HIV diagnosis and treatment considerations in the older HIV-infected patient.

Antiretroviral Drug Cost Table (Appendix C)
This new table lists the monthly average wholesale price (AWP) for U.S. Food and Drug Administration (FDA)-approved brand and generic antiretroviral (ARV) drugs, including fixed-dose combination products. (The AWP listed for an ARV may not represent the pharmacy acquisition price or the price paid by consumers for that drug.)

Key Updates to Existing Sections

Following are key updates to existing sections of the guidelines.

Initiating Antiretroviral Therapy in Treatment-Naive Patients

The Panel updated its recommendations on initiation of ART in treatment-naive patients. The changes are primarily based on increasing evidence showing the harmful impact of ongoing HIV replication on AIDS and non-AIDS disease progression. In addition, the updated recommendations reflect emerging data showing the benefit of effective ART in preventing secondary transmission of HIV. The updated section includes more in-depth discussion on the rationale for these recommendations and on the risks and benefits of long-term ART.

The Panel’s recommendations are listed below.

• ART is recommended for all HIV-infected individuals. The strength of this recommendation^a varies on the basis of pretreatment CD4 cell count:
• CD4 count <350 cells/mm³ (AI)
• CD4 count 350 to 500 cells/mm³ (AII)
• CD4 count >500 cells/mm³ (BIII)

• Regardless of CD4 count, initiation of ART is strongly recommended for individuals with the following conditions:
• Pregnancy (AI) (see perinatal guidelines for more detailed discussion)
• History of an AIDS-defining illness (AI)
• HIV-associated nephropathy (HIVAN) (AII)
• HIV/hepatitis B virus (HBV) coinfection (AII)

• Effective ART also has been shown to prevent transmission of HIV from an infected individual to a sexual partner. Therefore, ART should be offered to patients who are at risk of transmitting HIV to sexual partners (AI[heterosexuals] or AIII [other transmission risk groups]).

• Patients starting ART should be willing and able to commit to treatment and should understand the benefits and risks of therapy and the importance of adherence (AIII). Patients may choose to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy on the basis of clinical and/or psychosocial factors.

HIV-Infected Women
This revised section includes an expanded discussion on the use of hormonal contraception in HIV-infected women. The discussion focuses on drug-drug interactions between combined oral contraceptives and ARV drugs as well as on recent data showing a possible association between hormonal contraceptive use and acquisition or transmission of HIV.

HIV/Hepatitis C Coinfection
Updates to this section focus on the newly approved HCV NS3/4A protease inhibitors (PIs) boceprevir and telaprevir, the known interactions between these drugs and ART, and interim results from current ongoing research in HIV/HCV coinfected patients. The updated section includes preliminary recommendations on coadministration of the HCV NS3/4A drugs and ART.

Mycobacterium Tuberculosis Disease with HIV Coinfection
This update provides recommendations for timing of initiation of ART in HIV-infected patients who have been diagnosed with tuberculosis (TB) and are not receiving ART. The recommendations are based on results from randomized controlled trials showing survival benefits (1) when ART was initiated during rather than after TB treatment and (2) when ART was started within 2 weeks of TB treatment in patients with pretreatment CD4 count <50 cells/mm³. The updated section provides more in-depth discussions on the evidence and rationale supporting the recommendations.

The Panel’s recommendations are as follows:

•  For patients with CD4 counts <50 cells/mm³, ART should be initiated within 2 weeks of starting TB treatment (AI).
•  For patients with CD4 counts >50 cells/mm³ with clinical disease of major severity as indicated by clinical evaluation (including low Karnofsky score, low body mass index [BMI], low hemoglobin, low albumin, organ system dysfunction, or extent of disease), the Panel recommends initiation of ART within 2 to 4 weeks of starting TB treatment (BI for CD4 count 50–200 cells/mm³ and BIII for CD4 count >200 cells/mm³).
•  For other patients with CD4 counts >50 cells/mm3, ART can be delayed beyond 2 to 4 weeks but should be initiated by 8 to 12 weeks of TB therapy (AI for CD4 count 50–500 cells/mm3; BIII for CD4 count >500 cells/mm3).

Drug Interaction Tables (Tables 14–16b)
These tables are updated with recent data on pharmacokinetic (PK) interactions between ARV drugs and other drugs commonly prescribed for HIV-infected patients and the Panel’s recommendations on coadministration of these drugs. The key updates include:

• Change in recommendation on dosing of rifabutin with HIV PIs
• New recommendation to not use HIV PIs and non-nucleoside reverse transcriptase inhibitors (NNRTIs) with rifapentine
• Addition of information on interactions of boceprevir and telaprevir with different ARV drugs and related recommendations
• Update of interactions between different ritonavir-boosted PI and HMG-CoA reductase inhibitors.

Prevention of Secondary HIV Transmission
This section is updated to discuss the role of effective ART in preventing HIV transmission. The updated section also indicates evidence-based interventions available to assist providers with HIV risk behavior identification and counseling.

Additional Updates

Minor revisions have also been made to the following sections:

• Treatment Goals
• What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient (new information regarding adverse effects of raltegravir)
• HIV and Illicit Drug Users (new drug interaction added to Table 11 included in the section)
• Adherence to Antiretroviral Therapy
• Adverse Effects of Antiretroviral Agents (and accompanying Table 13)
• Drug Characteristics Tables (Appendix B)

By Tim Horn

Published on March 23, 2o12 on AIDSMEDS

Although hepatitis C virus (HCV) is a common and serious coinfection among people living with HIV, it often goes undiagnosed, even in a major U.S. city with multiple HIV care providers and a clinic dedicated to caring for people with both infections. This is the finding of a Miami cohort study reported Tuesday, March 6, at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle.

Conducted by Khaled Deeb, MD, of the University of Miami’s Miller School of Medicine and his colleagues, the analysis presented in Seattle involved a medical chart review of 14,900 people living with HIV, who were in care for more than a year during the period between 2000 and 2011.

Click HERE to read the full article at AIDSMEDS

Click HERE to view the Cohort Study

This articel is courtesy of AIDSMEDS

 

  By Oriol R. Gutierrez Jr.

Published March 27, 2012 on POZ Blogs

The 10th annual LGBT Health Awareness Week runs from March 26 to 30. The National Coalition for LGBT Health organizes the event, which is a call to action to recognize health and wellness as an essential part of the LGBT social justice movement.

“Come Out for Health” is this year’s theme. The goal is to advance four core LGBT health principles: consumer empowerment, culturally competent services, engaged communities and inclusive policymaking.

Click HERE to read the full article on POZ Blogs

Click HERE to read more about “Come Out for Health” on The National Coalition for LGBT Health’s website.

This article is courtesy of POZ Blogs

Treatment of Anal Intraepithelial Neoplasia in HIV⁺ MSM: A Triple-arm Randomized Clinical Trial of Imiquimod, Topical 5-Fluoruracil, and Electrocautery

Olivier Richel, H De Vries, C Van Noesel, M Dijkgraaf, and J Prins; Academic Med Ctr, Amsterdam, The Netherlands

Background:  Anal cancer is an increasing problem among HIV⁺ men-who-have-sex-with-men (MSM). Screening for its precursor lesion, anal intraepithelial neoplasia (AIN), is subject of discussion. Current treatment options are suboptimal and have not been compared in a prospective trial. In this randomized clinical trial we compared efficacy and side effects of imiquimod, topical 5-fluoruracil (5-FU), and electrocautery for the treatment of AIN.

Methods:  We randomized 148 HIV⁺ MSM with histologically confirmed AIN among 16 weeks of imiquimod (3 times a week), 5-FU (twice a week), and monthly electrocautery for 4 months. Participants were evaluated by high-resolution anoscopy with biopsies 4 weeks and 6 months after treatment. Response rates were compared by c² analysis.

Results:  Of all patients, 57% had high-grade (HG) AIN. In an intent-to-treat analysis, imiquimod showed a response rate of 39% (95%CI 27 to 52), 5-FU of 29% (95%CI 18 to 43), and electrocautery of 48% (95%CI 34 to 62). Complete response was seen in 26% (95%CI 16 to 39), 17% (95%CI 8 to 30), and 41% (95%CI 28 to 56), respectively (p = 0.03), of which 25%, 57%, and 17% recurred 6 months after treatment. In a multivariate logistic regression, HGAIN, peri-anal AIN and high plasma CD4 cell count were significantly associated with response to treatment, with odds ratios of 3.5 (p = 0.003), 31.9 (p = 0.003), and 1.003 (per cell/µL; p = 0.002), respectively. Severe side effects were seen in 43% (imiquimod), 27% (5-FU), and 18% (ECA) (p = 0.02).

Conclusions: This study showed that regarding both efficacy and side effects electrocautery is superior to imiquimod and 5-FU in treatment of AIN, but recurrence rates are substantial.

____________________________________________________________________________________________________________________________________________________

An Article by Tim Horn at AIDSmeds.com

When it comes to treating precancerous anal lesions, electrocauterization is both more effective and, somewhat surprisingly, better tolerated than repeated topical applications of either Aldara (imiquimod) or Efudex (fluorouracil), according to data presented Thursday, March 8, at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.  Lead presenter Olivier Richel, MD, of the Academic Medical Center in Amsterdam noted, however, recurrence rates were high with all treatments tested in the study.

As explained by Richel, between 50 and 80 percent of HIV-positive men who have sex with men (MSM) will experience anal lesions—anal intraepithelial neoplasia (AIN)—caused by human papillomavirus (HPV) and that up to 50 percent will develop high-grade AIN, or HGAIN. HGAIN, cause by oncogenic strains of HPV, are precancerous lesions, with approximately 15 percent of HIV-positive MSM developing anal cancer within five years of developing high-grade lesions.

Numerous questions abound regarding the diagnosis and treatment of AIN. For example, it’s still not clear if aggressive screening for anal lesions has a profound effect on anal cancer rates, at least not to the extent that regular Pap smears have helped reduce cervical cancer rates among women. It is also unclear whether HIV-positive men and women should be screened for AIN using Pap smears or if more expensive and invasive direct visualization—high-resolution anoscopy, for example—should be the preferred first-line screening method.

As for treatment, Richel noted that numerous options exist. One option is cauterization—an outpatient procedure in which affected anal tissue is burned and destroyed. Cauterization, using either electric or infrared technology, is approximately 50 to 70 percent effective but ais associated with high recurrence rates. Aldara, when applied to tissue inside the anus, was found to be partially or completely effective in up to 29 percent of patients in a small study reported in 2010. Efudex was partially or completely effective in up to 39 percent of AIN patients in a small study reported in 2011.

Richel and his colleagues set out to compare these three options in a study involving 148 HIV-positive MSM with biopsy confirmed low-grade or high-grade AIN. The men averaged 47 years of age and had been diagnosed with HIV seven to 10 years prior. More than 80 percent were on an antiretroviral regimen upon entering the study and more than three-quarters had undetectable viral loads. Average CD4 cell counts were between 535 and 590.

Between 54 and 60 percent of the men had HGAIN and roughly 95 percent had evidence of AIN lesions inside their anuses.

Forty-six men were randomized to receive electrocauterization once a month for four months.  Among the 54 men allotted to the Aldara group, the cream was applied three times a week for 16 weeks. The 48 men in the Efudex group received topical treatment twice a week for 16 weeks.

Thirty six, 45 and 43 men, respectively, successfully completed the study as planned. Three men in the electrocauterization group, compared with 5 men in the Aldara group and 2 men in the Efudex group, discontinued treatment in the study because of side effects.

In the strict intent-to-treat analysis—which included all people randomized in the study, regardless of whether or not they completed their treatment course and follow-up appointments—electrocauterization proved most effective, with 41 percent achieving a complete response and 7 percent achieving a partial response. Seventeen percent, however, saw AIN recur within six months after treatment.

In the Aldara group, complete responses were seen in 26 percent and partial responses were documented in 13 percent.  Twenty-five percent of the partial or complete responders experienced AIN recurrence within six months.

As for those receiving Efudex, the complete response rate was 17 percent and the partial response rate was 13 percent. Fifty-seven percent experienced disease recurrence within six months.

As for side effects in the electrocauterization group, 60 percent experienced pain and 69 percent had bleeding, though Richel noted that these problems only lasted a few days following the procedure. In the Aldara and Efudex groups, side effects lasted for weeks, and included pain (60 to 67 percent), bleeding (30 to 40 percent), sudden bowel movement urges (Efudex; 26 percent), flatulence (Efudex; 15 percent), flu-like symptoms (Aldara; 13 percent) and fatigue (Aldara; 13 percent).

Richel also noted that severe side effects were more common in the Aldara group (43 percent) and Efudex group (27 percent) compared with the electrocauterization group (18 percent).

“This study showed that regarding both efficacy and side effects electrocautery is superior to [Aldara] and [Efudex] in treatment of AIN, but recurrence rates are substantial,” Richel and his colleagues concluded.

By Regina McEnery

Earvin “Magic” Johnson, the Los Angeles Lakers basketball star whose megawatt smile was about as famous as the dazzling moves that inspired his nickname, shocked the sports world on Nov. 7, 1991, when he announced that he had contracted HIV and would retire that day from the Lakers.

In a 90-minute documentary, entitled “The Announcement,” narrated by Johnson and produced by ESPN Films for the network’s entertainment television channels, the basketball legend recounts the tense private moments leading up to his explosive disclosure, describing, among other things, his anguish at the thought that he may have infected his wife, Cookie, and their unborn child. It turned out he had not. Still, Cookie was opposed to his making a public announcement. This was not surprising. The nation, and certainly the world of professional sports, hadn’t quite come to terms with the HIV epidemic.

But the diagnosis was not a death sentence, as many at the time assumed it would be. Thanks to a new class of HIV drugs called protease inhibitors and the development of highly active antiretroviral therapy (HAART), Johnson has lived a relatively healthy life with the virus for more than 20 years. He has in that time become an inspiring advocate for the treatment and prevention of HIV infection, working to remove the stigma associated with HIV, which today infects more than 33 million people worldwide. The documentary is as much about how Johnson has lived with his diagnosis as it is about the impact of his announcement, which shocked his friends and fans and left many in tears. The film first aired on March 11 and is scheduled to be shown through April 14.

A second documentary, “How to Survive a Plague,” by journalist and first-time director Donald France, examines how the activist group, AIDS Coalition to Unleash Power (ACT UP)—and the Treatment Action Group, an offshoot of ACT UP—drew attention to the HIV epidemic. Scores of gay activists, terrified by the specter of AIDS in the 1980s and 1990s, fought to save the sick and dying using a range of aggressive tactics that included not only protests at Capitol Hill but such antics as infiltrating the set of a nightly news broadcast and marching outside the home of Anthony Fauci, the director of the US Institute for Allergy and Infectious Diseases, which was funding many of the AIDS drug trials.

Fifteen years after the first cases of AIDS were detected, HAART was rescuing AIDS patients from the brink of death and transforming the US epidemic. ACT UP is credited with putting AIDS on the national health agenda and so speeding these developments. Two special screenings of the documentary were held in New York City in March—on the 25th anniversary of the very first ACT UP demonstration. It is due to open in theatres this fall.

            

This article is from VAX: The Bulletin on AIDS Vaccine Research.  Download the full March bulletin here:[Download not found]